Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information. |
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Device | PRIZM & VITALITY FAMILIES |
Generic Name | Implantable pulse generator, pacemaker (non-CRT) |
Applicant | BOSTON SCIENTIFIC 4100 Hamline Avenue North St. Paul, MN 55112 |
PMA Number | P960040 |
Supplement Number | S150 |
Date Received | 09/05/2007 |
Decision Date | 11/06/2007 |
Product Code |
LWP |
Advisory Committee |
Cardiovascular |
Supplement Type | Real-Time Process |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Recalls | CDRH Recalls |
Approval Order Statement APPROVAL FOR THE LATITUDE COMMUNICATOR SOFTWARE (MODEL 6482), VERSION 2.0 AND RELATED SYSTEM SOFTWARE (MODEL 6488) THAT CONTAINS REGULATED APPLICATION SERVER (RAS) SOFTWARE VERSION 2.3.0 AS WELL AS ASSOCIATED LABELING AND OPERATOR MANUAL UPDATES. THE SOFTWARE MODIFICATIONS ARE INTENDED TO SUPPORT NEW DEVICE MODELS, MAKE MINOR SOFTWARE CORRECTIONS, AND IMPROVE EASE OF USE WITH THE LATITUDE SYSTEM. |
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